Welcome to our dedicated page for BioXcel Therapeutics news (Ticker: BTAI), a resource for investors and traders seeking the latest updates and insights on BioXcel Therapeutics stock.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a pioneering clinical-stage biopharmaceutical company that harnesses the power of artificial intelligence (AI) to identify and develop the next generation of transformative medicines. Focusing on neuroscience and immuno-oncology, BioXcel re-innovates existing approved drugs and clinically validated candidates using proprietary machine learning algorithms and big data. This innovative approach allows the company to discover new therapeutic indications more efficiently.
BioXcel's two leading clinical programs are BXCL501 and BXCL701. BXCL501, marketed as IGALMI, is an FDA-approved sublingual film formulation of dexmedetomidine used for the acute treatment of agitation associated with schizophrenia or bipolar I and II disorder in adults. This product is undergoing further development to expand its use for agitation in dementia related to probable Alzheimer’s disease and for at-home use.
BXCL701 is an oral innate immune activator designed to inflame the tumor microenvironment, enhancing the efficacy of checkpoint inhibitors. It is currently being investigated for the treatment of rare forms of prostate cancer and pancreatic cancer. The company recently reported promising results from a Phase 2 trial of BXCL701 in combination with KEYTRUDA for metastatic pancreatic ductal adenocarcinoma (PDAC).
BioXcel also continues to strengthen its intellectual property portfolio, with over 100 patent applications in prosecution and multiple patents issued globally. The company's financial performance reflects a commitment to advancing its clinical pipeline; for example, net revenue from IGALMI increased significantly in the first quarter of 2024, driven by growing demand and new customer acquisitions.
The company maintains a strong focus on advancing its TRANQUILITY and SERENITY programs, designed to evaluate BXCL501 in treating agitation in various settings, including at home. Additionally, BioXcel's strategic collaborations with institutions like Georgetown University's Lombardi Comprehensive Cancer Center underline its dedication to innovative cancer therapies.
For ongoing updates, BioXcel engages with the investment community through regular conference calls and webcasts and actively participates in key industry conferences like the American Society of Clinical Oncology (ASCO) Annual Meeting. For more information and the latest news, please visit bioxceltherapeutics.com.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced participation in investor conferences, featuring CEO Vimal Mehta and CCO Matt Wiley. They will discuss the company's neuroscience and immuno-oncology programs, highlighting their AI platform aimed at enhancing drug discovery. Key events include the Guggenheim 4th Annual Immunology and Neurology Day on November 14, 2022, at 3:20 PM ET in New York City, and the Jefferies 2022 London Healthcare Conference on November 16, 2022, at 11:30 AM GMT. Webcasts can be accessed on the company's website.
BioXcel Therapeutics (BTAI) reported third quarter 2022 results, revealing a net revenue of $137,000 amidst heightened R&D expenses of $22.1 million, primarily linked to its BXCL501 clinical program. The company also posted a net loss of $41.8 million, up from $26.8 million year-on-year. Despite these losses, BioXcel is advancing its agitation-treatment market position with IGALMI™ and anticipates pivotal trial data for BXCL501 in Alzheimer’s-related agitation and bipolar disorders in 1H 2023. The firm maintains a cash balance of approximately $232.3 million as of September 30, 2022.
BioXcel Therapeutics (BTAI) has announced the release of its third quarter 2022 financial results set for November 10, 2022. The management team will hold a conference call at 8:30 AM ET to discuss these financial results and provide a business update. The financials are anticipated to cover performance metrics relevant to shareholders and the company’s AI-driven drug development in neuroscience and immuno-oncology.
BioXcel Therapeutics (Nasdaq: BTAI) has announced a Commercial Day presentation on October 18, 2022, to update on IGALMI™ (dexmedetomidine) sublingual film, a treatment for acute agitation linked to schizophrenia and bipolar disorders in adults. Key company leaders and healthcare experts will share insights on clinical applications and market strategies. IGALMI, approved by the FDA in April 2022, is administered under medical supervision due to potential serious side effects. Investors can RSVP for the event and access a live webcast via BioXcel's website.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta and CCO Matt Wiley will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 10:30 a.m. ET. The discussion will focus on the company’s neuroscience and immuno-oncology programs and its AI platform for drug discovery. They will also outline the commercial launch strategy for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in adults with schizophrenia or bipolar disorder. A live webcast will be accessible on the company's website.
BioXcel Therapeutics (BTAI) has commercially launched IGALMI™ (dexmedetomidine) for the acute treatment of agitation in bipolar I/II disorder and schizophrenia in adults. The company plans to initiate the SERENITY III pivotal trial for at-home use of BXCL501 in 2H 2022, following a positive FDA Type B meeting. They expect top-line data from the TRANQUILITY II trial for Alzheimer's-related agitation in 1H 2023. BioXcel reported a net loss of $37.7 million for Q2 2022, with cash reserves of approximately $233.5 million, ensuring funding into 2025.
BioXcel Therapeutics (Nasdaq: BTAI) announces participation in the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 2:30 p.m. ET. CEO Vimal Mehta and CCO Matt Wiley will discuss the company's neuroscience and immuno-oncology programs, along with its AI-driven drug discovery platform. The event will also cover the commercial strategy for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in adults. A live webcast will be available on their website 15 minutes before the chat starts.
BioXcel Therapeutics (BTAI) announced a multi-year NIDA grant of approximately $3.3 million to fund a clinical study of BXCL501 for opioid withdrawal treatment. The grant will support a 160-patient Phase 2b trial comparing different doses of BXCL501 against placebo and Lucemyra™. This research responds to a significant health crisis, with over 142 million opioid prescriptions dispensed in the U.S. in 2020. Early trials indicated BXCL501 is well tolerated and may effectively reduce insomnia and anxiety in patients. Further funding of about $4.5 million will depend on achieving specific milestones.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) will release its second quarter 2022 financial results on August 9, 2022, before U.S. market opening. A conference call and webcast will take place at 8:30 AM ET to discuss the results and provide business updates. BioXcel utilizes artificial intelligence for drug re-innovation in neuroscience and immuno-oncology. Its product, IGALMI™, is approved for treating agitation in schizophrenia and bipolar disorders. The company is also pursuing treatments for Alzheimer's-related agitation and prostate cancer.
BioXcel Therapeutics (BTAI) announced the appointment of Michael P. Miller to its Board of Directors, effective July 1, 2022. Miller has nearly 40 years of experience in the pharmaceutical industry, previously serving as EVP, U.S. Commercial at Jazz Pharmaceuticals. His leadership is expected to enhance BioXcel's commercial capabilities as the company launches its product IGALMI, a sublingual film for treating agitation linked to Alzheimer's disease. Miller's extensive background in product launches and market access is viewed as crucial for the company's growth trajectory.
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